Business
POLB001 Update - Clinical Trial Agreement Signed
POLB001 Update - Clinical Trial Agreement Signed.
About this update from Poolbeg Pharma Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 6800G\n Poolbeg Pharma PLC\n 31 March 2022\n \n \n \n \n Poolbeg Pharma plc\n \n \n \n \n \n POLB 001 Clinical Development - Clinical Trial Agreement Signed\n \n \n On track to commence LPS human challenge clinical trial in June 2022 \n \n \n \n 31 March, 2022 - \n \n Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company') announces that it has signed a Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in the Netherlands for the completion of a bacterial lipopolysaccharide ('LPS') human challenge study of POLB 001, which is due to commence in June 2022. First results are expected before the end of 2022 at which point the Company aims to rapidly monetise by partnering or out licensing the asset to pharma / biotech for further development.\n \n As part of this study, which is being completed in line with the Company's capital light approach, researchers will stimulate the immune systems of healthy volunteers with LPS in a safe and controlled clinical environment. LPS emulates a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections which CHDR will use to measure the efficacy of POLB 001 as its mode of action is to block this hyper-immune response. This differs from existing treatments because it targets the host immune response rather than the virus itself and is therefore unaffected by viral variance. Poolbeg has defined and formulated the oral administration of POLB 001 and already has sufficient grade and quantities of the drug to utilise immediately in the forthcoming human challenge study.\n \n \n In the study the LPS will be administered both intradermally (a shallow injection) and intravenously (an injection of a vein). By administering the LPS intradermally, the Company can gather data around the localised response of the body to POLB 001. By then administering the LPS intravenously, data can be gathered around the full body systemic response to POLB 001. By using both methods within one study, the Company will efficiently and cost effectively collect both local and systemic efficacy data, increasing the value of the data package which will be attractive to potential partners. Overall, the study will generate key human data on the efficacy of POLB 001 in dampening the immune response in...